2 Guidance for the prevention, testing, treatment and management of hepatitis C in primary care Working Party: Chris Ford, Kate Halliday, Graham Foster, Charles Gore, Kate Jack, Nicola Rowan, Carola Sander-Hess, Sebastian Saville, Brian Thomson, Stephen Willott, Nat Wright and David Young Available at and Thanks to: Gary Brook, Clare Gerada, Ewen Stewart, Siobhan Fahey and many others Supported by the Alliance Produced with the help of an educational grant from Schering-Plough Completed May 2007 For review 2010 Disclaimer This publication is intended for the use of medical practitioners in the UK and not for patients. The authors, editors and publishers have taken care to ensure that the information contained in this book is correct to the best of their knowledge, at the time of publication. While efforts have been made to ensure the accuracy of the information presented, particularly that related to the prescription of drugs, the authors, editors and publishers cannot accept liability for information that is subsequently shown to be wrong. Readers are advised to check that the information, especially that related to drug usage, complies with information contained in the British Formulary, or equivalent, or manufacturers datasheets, and that it complies with the latest legislation and standards of practice.

3 Guidance for the prevention, testing, treatment and management of hepatitis C in primary care i Contents Executive summary iii Why this guidance? 1 Who is this guidance for? 2 What is hepatitis C? 2 Epidemiology 2 Natural history of HCV 2 Signs and symptoms of hepatitis C 2 Acute hepatitis C 2 Chronic hepatitis C 3 Long term outlook for the patient 3 Predictors of HCV disease progression 5 Transmission of hepatitis C 5 Making the diagnosis 6 Testing in general practice 7 What to test 7 Why test 8 Who should be tested 9 What information do patients need 9 Before testing 9 After testing 10 Other investigations to consider in general practice if hepatitis C antibody positive 11 Prevention 12 Special groups 15 Mother to baby (vertical transmission) 15 Children 15 Prisoners 15 Referral what will happen next? 16

5 Guidance for the prevention, testing, treatment and management of hepatitis C in primary care iii Executive summary Introduction 1. Hepatitis C infection is an under-diagnosed (five out of every six people infected are undiagnosed) and under-treated important cause of morbidity and mortality. 2. Hepatitis C is a common and potentially curable disease, but only 1 to 2% of infected people are currently receiving National Institute of Clinical Excellence (NICE) recommended therapy. 3. Every general practitioner is likely to have between 8 to 18 infected individuals per GP, based on an average list size of 1,800 and, partly depending upon local population demographics. Many of these patients may not be diagnosed and knowledge about HCV in population and primary care remains low but improving. 4. Prevalence of the hepatitis C virus (HCV) is estimated to be between 0.4 to 1% of the United Kingdom (UK) population, equating to be between 250,000 to 600,000 sufferers. Worldwide there are an estimated 170 million people, about 3% of the world s population, who are chronically infected with HCV. 5. HCV is a blood-borne ribonucleic acid (RNA) virus that exists as a number of different strains (genotypes) and an important cause of liver disease. The effects of the infection vary from one individual to the next. Some people will remain symptom free, some will develop cirrhosis and others will develop liver failure or hepatocellular (or primary liver) cancer. Transmission and prevention 1. Unlike hepatitis A and B, there is no vaccine but infection is avoidable through strategies that reduce transmission. 2. Major route of transmission in the UK is sharing injecting equipment. Other risk factors include: blood transfusion (prior to 1991) or blood products (prior to 1987) and born or spent a significant amount of time in a high risk country. This may include health care given in early childhood so those born in the developing world may be at increased risk. A small but important number of infected people have acquired their infection through the use of non-sterile surgical equipment. This is most likely in those who have received health care in the developing world, including East Europe and Africa. 3. Practical suggestions to help prevention in primary care: a) Provide hepatitis A and B vaccinations in all patients using drugs and other high risk groups such as men who have sex with men. b) Provide clear information about safer injecting and safer sex including condoms. c) Ensure that all patients using drugs have easy convenient access to local needle exchanges, which provide injecting paraphernalia as well as needles and syringes and advise about safer smoking and snorting of drugs. d) Advise injectors of strategies how to move away from injecting. e) Run a needle exchange in the surgery. f) Discuss alcohol with all patients, advise to stop and treat or refer on any alcohol problem. g) Provide drug treatment including substitute medication or refer to secondary agency for help. h) Monitor weight and provide help with weight reduction (risk of non-alcoholic fatty liver disease which causes cirrhosis irrespective of any other causes) and provide nutrition advice and support people who are HCV positive to optimise their nutrition. i) Advice all patients to stop smoking and explain to people who are HCV positive that smoking can increase progression.

6 iv Guidance for the prevention, testing, treatment and management of hepatitis C in primary care Executive summary Testing 1. As HCV is under diagnosed, testing in general practice is important, after ideally assessing all patients for risk factors make no assumptions. 2. Ensure the patient understands the condition and the test before taking blood for: a) HCV antibody blood test, to check if patient has been exposed to the hepatitis C virus. b) HCV RNA (usually by a polymerase chain reaction (PCR)), to check if the infection is active or not. Disease outcomes and symptoms 1. Acute infection is usually asymptomatic but jaundice and malaise may occur. The incubation period of acute hepatitis C infection is usually between six and nine weeks, with the specific antibody usually present by three months from infection, although in some cases it may take up to six months before the antibody is detected. Most people who become infected with hepatitis C are unaware of it at the time. Around 25% of those infected with hepatitis C infection will clear the virus at the acute stage. 2. Chronic hepatitis C infection is a slowly progressive and often asymptomatic disease of the liver caused by the hepatitis C virus. Early studies in patients infected for up to 20 years indicated that the prevalence of cirrhosis was very low suggesting the disease progressed at a very slow rate. However recent studies suggest the disease does not progress in a linear fashion and that mild disease may accelerate with time so careful surveillance of all infected patients is important. Treatment 1. Early referral is advantageous. It is now thought that chronic HCV does not progress in a linear fashion and that the disease accelerates with ageing so most patients with HCV may develop cirrhosis long term. Furthermore therapy is more effective when administered in the early stages of the disease and hence early referral is advisable. 2. The most recent NICE guidance advocates treatment for all that want it including: a) active injectors b) for mild to moderate hepatitis C (previous NICE guidance was only for severe disease). 3. The current treatment is combination therapy with pegylated interferon and ribavirin. This treatment is successful in clearing the virus (defined as no detectable virus) six months after treatment has ceased) in between 40 to 80% of those treated, accordingly to genotype. 4. Where treatment is provided from a hospital base: primary care can continue to play an important role in the patient s treatment by providing ongoing General Medical Services (GMS) to support the patient through the treatment process, supporting patients on therapy and giving practical advice to them on managing side-effects such as paracetamol for pyrexia, anti emetics if nauseated and moisturisers and steroid cream for itchy skin along with ongoing harm reduction information, support regarding drug dependency and monitoring of mental health, especially depression. 3. Many with chronic hepatitis C infection will have no symptoms, while others will feel unwell to varying degrees. Symptoms, though not common, may include mild to severe fatigue, muscle aches, nausea, depression or anxiety, pain or discomfort in the liver and poor memory or concentration.

7 Guidance for the prevention, testing, treatment and management of hepatitis C in primary care 1 Why this guidance? This guidance has been produced to aid medical practitioners and others in the management of hepatitis C infection in Primary Care. Hepatitis C virus (HCV) was first identified in 1989 and rapidly emerged as a significant world public health problem. 1 The true prevalence of chronic hepatitis C (CHC) is unknown. Estimates remain vulnerable to the lack of information of the ever and current IDU population at risk of CHC, leading to wide ranges around best guesses. 2 The prevalence of HCV is estimated to be between 0.4 to 1% of the United Kingdom (UK) population, equating to be between 250,000 to 600,000 sufferers. 3, 4, 5, 6 Injecting drug users account for a large proportion of cases. Britain has a poor record in treating patients with chronic HCV, and out of the total population infected fewer than 17% have been diagnosed 7 and it is estimated that only about one in 20 of those who are diagnosed are treated each year. 8 Of the total number infected the treatment rate is less than 2%. 2, 8 According to The Health Protection Agency report on hepatitis C in 2005, deaths, transplants and hospital admissions for HCV-related end stage liver disease continue to increase... 9 The low rates of therapy for HCV infected patients in the UK are likely to lead to further increases in the late complications of chronic HCV. 5, 9 This has led many to describe hepatitis C as a public health time bomb and said this failure to address hepatitis C is not acceptable that may cost the NHS up to 8 billion over the next 30 years as increasing numbers of people suffering cirrhosis, liver failure and liver cancers present for therapy. 10 Every general practitioner is likely to have between 8 to 18 infected individuals, with an average list size of 1,800, partly depending upon the local population demographics. However many of these patients may be undiagnosed. Therefore up-to-date, accurate knowledge about transmission, diagnosis, testing and treatment etc of HCV in primary care is essential. As part of The Hepatitis C Action Plan (released by The Department of Health (DH) in 2004) 7 an educational booklet about HCV was sent to all general practitioners (GPs) in England and Wales. However independent follow up questionnaire assessments of GPs understanding of HCV suggest that knowledge remained poor. 11 This is compounded by the current poor understanding of HCV in the general population and professionals and by patients not coming forward for testing etc. 12 Further awareness campaigns for hepatitis C have been launched (the latest on-going campaign called FaCe It, commenced in 2004) with additional input to GPs. 13 However no evaluation has been published and anecdotal evidence indicated that the knowledge base in general practice was still poor. However a new report from the Health Protection Agency 5 shows that the number of people newly diagnosed with hepatitis C has increased; from 2,116 in 1996, to 7,580 in 2005, but this is still a small fraction of the total infected population. New figures also show that testing for hepatitis C has increased overall, for example, in GP surgeries, testing has increased by almost 60% between 2002 and The report goes on to say that the latest estimates on the number of adults infected with hepatitis C showed there were around 231,000 in Many of these infected people do not realise they have the virus as it can take years or even decades for symptoms to appear. Early treatment, however, is effective at clearing the virus in the majority of people. It is therefore important that individuals at risk are tested by their GP, drug service or other health services. The National Treatment Agency (NTA) have recently introduced targets to drug treatment services to offer HCV testing to and immunisation against HBV to 100% of patients in recognition that improvements need to be made in prevention and diagnosis. 14 In a majority of people hepatitis C is a curable disease and therapy is recommended by the National Institute for Clinical Excellence (NICE). 15, 16 This guidance has recently been updated (2006) and NICE now recommend treatment for mild to moderate disease, as well as severe disease. 15, 16 However treatment rates in the UK remain low despite the on-going patient awareness campaigns, NICE recommendations and pressure from informed clinicians and their patients. Diagnosed individuals in France are 6 to 12 times more likely to enter treatment programmes. 8 It seems probable that lack of awareness in primary care contributes to the low treatment rates in the UK and the purpose of this guidance is to provide clinical information about the management of hepatitis C infection in primary care that, hopefully, will lead to increased prevention of HCV transmission along with improved testing, diagnosis and treatment for patients who are already infected. This guidance is only one tool and should be accompanied by appropriate training. It has also been shown that general practice has an important role in the care of people at risk of hepatitis C and when appropriately supported can effectively implement current best practice. 17 This guidance is part of a series, which also includes the use of buprenorphine in opioid dependence treatment, treatment of cocaine users, hepatitis vaccination schedules (which have now been incorporated in this document as Appendix 5) and methadone in opioid dependence treatment. 18, 19, 20, 21 These documents are available online at and

8 2 Guidance for the prevention, testing, treatment and management of hepatitis C in primary care Who is the guidance for? This guidance is aimed at all general practitioners, practice nurses and other clinicians working in primary care. Also for all clinicians and others involved in the care of drug using patients. It has been developed specifically to increase knowledge about HCV, increase testing, prevention, referral for treatment and support the management of chronic hepatitis C in primary care. What is hepatitis C? Hepatitis C infection is a slowly progressive and often asymptomatic disease of the liver caused by the hepatitis C virus. HCV is a blood-borne ribonucleic acid (RNA) virus that exists as a number of different strains (genotypes) that are defined by molecular analysis of the viral genome. HCV is a blood-borne virus that causes liver and systemic disease. The effects of the infection vary from one individual to the next. Many people will remain symptom free, some will develop cirrhosis and a few will develop liver failure or primary liver cancer. Unlike hepatitis A and B, there is no vaccine but infection is preventable through strategies that reduce transmission. Epidemiology The prevalence of hepatitis C in the UK is between 0.4 to 1% equating to between 250,000 to 600,000 sufferers. 3, 4, 5, 6 The Health Protection Agency (HPA) estimate that in England the prevalence of hepatitis C in the general population is around 0.5%. 3, 5, 9 In Scotland the estimate is 0.8%. 22 From their figures the HPA also predict that of these positive people: 31% will be in current injectors, 57% in ex-idu and 12% in non-idu population. 5 Worldwide there are an estimated 170 million people, about 3% of the world s population, who are chronically infected with HCV. 1 In some parts of Europe and the Indian Sub-continent the prevalence of HCV infection is between 3 to 5%. 1 Patients being born or receiving health care in childhood in a high-risk countries are likely to have a higher prevalence of HCV. 23 Risks for infection in the UK include injecting drug use (past or current), receipt of blood transfusion (prior to 1991) or blood products (before about 1987), and receipt of health care abroad, including health care given in early childhood, or being born in the developing world may be at increased risk. 23 Other risk factors include sexual exposure, vertical transmission and renal failure requiring haemodialysis. 24 Of all cases of hepatitis C infection in the UK, injecting drug use accounts for transmission in most cases. Natural history of HCV The understanding of the natural history of hepatitis C has changed over the last few years. Early studies in patients infected for up to 20 years indicated that the prevalence of cirrhosis was very low suggesting the disease progressed at a very slow rate. 25 However recent studies suggest the disease does not progress in a linear fashion and that mild disease may accelerate with time. Thus a long history of hepatitis C that is associated with minimal liver fibrosis should NOT be interpreted as evidence that the disease will always be mild and referral for treatment, careful follow up or intervention is required to detect/avoid disease acceleration associated with aging. Further, it has recently become clear that individuals with HCV infection are at higher risk of both all-cause and liver-related mortality than standard populations emphasising the importance of careful surveillance of this group. 26 Signs and symptoms of hepatitis C Acute hepatitis C The incubation period of acute hepatitis C infection is usually between six and nine weeks, with the specific antibody (antihcv) usually present by three months from infection, although in some cases it may take up to six months before the antibody is detected. Detection of viral HCV RNA usually using PCR test may be the only marker in early infection. Most people who become infected with hepatitis C are unaware of it at the time hence the incidence of acute hepatitis C is unknown. Only between 25 to 35% show symptoms in the early stages and severe symptoms are rare. Some people may briefly feel unwell, with a mild flu like illness or may have nausea and vomiting and, rarely, jaundice. Between 30 to 50% patients with symptomatic infection spontaneous recover usually within three months. 27 Chronic hepatitis C Most patients will pass on to chronic hepatitis C without knowing they have it and they are at significant risk of cirrhosis and hepatocellular carcinoma (HCC). Many people will have no symptoms, while others will feel unwell to varying degrees. Most people will remain well and without symptoms for a number of years and this makes the infection difficult to recognise. Disease progression and severity is very variable and patients may not become symptomatic until their liver disease is advanced. Symptoms, though not common, may include mild to severe fatigue, muscle aches, nausea, depression or anxiety, pain or discomfort in the liver and poor memory or concentration. Symptoms tend to affect much more that just the liver and there is increasing evidence about the effect on the brain and hence the quality of life. 28

9 Guidance for the prevention, testing, treatment and management of hepatitis C in primary care 3 Changes in quality of life with hepatitis C infection Controls Mild disease Severe disease Physical functioning Social functioning Role Physical Role Emotional Mental health Energy & fatigue Pain General health perception Figure 1 Many of these symptoms may come and go and symptoms may be wrongly diagnosed as due to on going drug use or occasionally as due to a chronic fatigue syndrome. It should be noted that the severity of symptoms does not necessarily equate to the extent of liver damage. Some patients will report quite severe symptoms with no clinical signs of liver disease, while cirrhosis can be present without any obvious symptoms. Individuals in whom the disease has progressed to cirrhosis may present with complications of decompensated liver disease, including oesophageal varices, ascites, bleeding and hepatic encephalopathy. Cirrhosis can also lead to hepatocellular carcinoma, a type of liver cancer. It has a high mortality rate. Screening using alfa fetoprotein (not very specific) and six-monthly ultrasounds should be undertaken in patients with cirrhosis. Long-term outlook for the patient Current evidence suggests that: around 25% of those infected with hepatitis C infection will clear the virus at the acute stage. 29 Of the 75% who do not: Some will remain well, and never develop liver damage. Many will develop only mild to moderate liver damage (with or without symptoms). Most will progress to cirrhosis of the liver over a period of 20 to 40 years. The outcome for those infected for more than 20 years is not yet clear but most studies indicate that a significant increase in the proportion with cirrhosis is likely with increasing age. A proportion of those with cirrhosis will progress to liver failure or HCC, approximately 5% per year will develop a life-threatening event.

10 4 Guidance for the prevention, testing, treatment and management of hepatitis C in primary care Disease progression in hepatitis C infection 100 people exposed to hepatitis C 75 to 80 people develop chronic hepatitis C 20 to 25 people clear the virus within two to six months Some will remain well and never develop liver damage Most people will develop some level of long term symptoms or signs of liver inflammation In time many will develop cirrhosis of the liver (over an average 20 to 40 years) and 5% of those with cirrhosis will develop liver failure or cancer per year. Figure 2 Prevalence of hepatitis C-related cirrhosis in elderly Asian patients infected in childhood 23 Percent of patients with cirrhosis Asians Caucasians >70 Age of patients Figure 3

11 Guidance for the prevention, testing, treatment and management of hepatitis C in primary care 5 Predictors of HCV disease progression Numerous studies have attempted to determine predictors of disease progression to cirrhosis. These studies indicate that some factors influence this progression, including: Alcohol consumption 30 Alcohol is strongly associated with increased likelihood of progression to severe liver complications. Progression to cirrhosis is higher in those who drink excessively. Faster progression is found in those who have previously drunk more than 50 units of alcohol a week for more than five years. Age at infection 31 Those who acquire hepatitis C at an older age have a more rapidly progressing disease and reduced time from infection to cirrhosis. Gender 6 Studies indicate that men are more likely to progress to cirrhosis than women. Ethnicity In patients of different race there has been noted variations in disease progression. CHC appears to progress less rapidly in African-American patients than non African-American patients. 32 Early reports suggest the disease may be worse in Asian patients. In one study of elderly Asian patients with chronic HCV nearly all those over the age of 60 had cirrhosis. 23 Co-infection with human immunodeficiency virus (HIV) or hepatitis A and/or B Those who are also co-infected with either HIV and/or hepatitis B and/or A are likely to progress to serious disease more rapidly. 6, 33, 34, 35, 36 Viral genotype Has no effect on disease progression but different genotypes have different sensitivities to therapy. 6, 31 Weight Body mass index above 25 has been associated with hepatic steotosis and, in some studies, more rapid disease progression. 37 Transmission of hepatitis C The hepatitis C virus is carried in the blood and has been detected in other body fluids. However, blood has been identified as the only vehicle of infection and blood to blood contact is a very effective way of transmitting HCV. 39 Sharing injecting and other drug paraphernalia The major route of HCV transmission in the UK is believed to be by sharing equipment for injecting drug use, mainly via blood-contaminated needles and syringes. Spoons, water and filters may also be vehicles of infection. It is estimated that between 30 to 80% of all current injectors have been infected with hepatitis. 40 The corresponding rate for past injectors is thought to be higher. Sharing pipes for smoking and straws for snorting can also transmit HCV, particularly if there are cuts or damage to the lips or nose and blood present. Blood transfusions and blood products Prior to the introduction of screening of all blood donations in 1991, there was a risk to recipients of blood. A heat treatment process to protect blood clotting factors (used in the treatment of haemophilia) against hepatitis C and other viruses was introduced in the mid-1980s (treated Factor IX available in 1985 and Factor VIII in 1987). There is a high prevalence of hepatitis C in people with haemophilia who received untreated clotting factors before these dates. 41 However, HCV should still be considered in patients from overseas or who have travelled abroad, who have had blood transfusions or surgery. Mother to baby transmission Mother to baby transmission does occur in women who are HCV and PCR positive, either in utero or at the time of birth, but appears to be uncommon, with upper estimates of 6% across the UK. 42 There seems to be no reduction if caesarean section is performed. 43 Transmission does not occur if the woman is HCV RNA negative. However, this is increased to around 15 to 20% when there is co-infection with HIV. There is no association proven between breastfeeding and transmission of hepatitis C infection and mothers with only this infection should not be advised against breastfeeding. 42, 43 Smoking Smoking is an independent risk factor of hepatic inflammation in patients with chronic hepatitis C (CHC). 38

12 6 Guidance for the prevention, testing, treatment and management of hepatitis C in primary care Sexual transmission Sexual transmission of hepatitis C is possible but uncommon. 44 The prevalence of hepatitis C among attendees of genitourinary clinics who are either heterosexuals (non-injecting) or men who have sex with men, is relatively low, 0.3 to 0.8%. 44 There is a 3% lifetime risk of transmission if the partner is positive. 44 In men who have sex with men recent changes in sexual practices may have led to a number of cases of HCV infection. Several hundred such infections have been seen in London and Brighton over the last few years and, although the precise risk factor is not yet understood, it is probable that traumatic anal sex may carry an above average risk of HCV transmission. The issue of sexual transmission is difficult and a consensus is not available. It is felt by some that figures of 3% are in large part due to shared risk factors and this view is supported by the article in American Journal of Gastroenterology which analysed over 8,000 patient years in 800 heterosexual couples and did not find a single instance of sexual transmission of HCV. 45 Generally patients can be advised that they are low risk of sexual transmission of HCV but they should consider using condoms. When HCV positive patients are coinfected with HIV they are more likely to transmit HCV to their sexual partners and they should be advised always to use condoms and practice safer sex. 46 One unit, in Nottingham, England, generally advises that there is no evidence to support the need for barrier methods of contraception (unless co-infected with HIV) within a stable relationship but that such devices should, of course, be used outside this context. This unit does not regard sexual partners as at high risk but will screen at request. Endemic in some countries There is a higher rate of infection in some countries, probably due to sexual transmission, unsafe obstetric practice, childhood inoculations, childhood rituals, shaving children, use of unsterilised needles and the widespread practice of needle re-use in many countries. There are prevalence rates of 1.7% in Americas, 5.3% in Africa, 4.6% in Eastern Mediterranean, 1.03% Europe, 3.9% in South-east Asia, and Western Pacific in 2.15%. 1 The prevalence among the Pakistani population (born abroad) in East London appears to be around 4%. 47 A further risk factor is frequent travel abroad (e.g. those visiting families in developing countries). Procedures abroad Transmission can occur through medical and dental procedures abroad, including therapeutic injections, blood transfusions, circumcisions where infection control may be inadequate. Tattoos and/or body piercing There is a risk from tattooing, ear piercing, body piercing and acupuncture with unsterile equipment in the UK or abroad. Examples may be homemade piercing in prison using re-used equipment. Household contact and sharing toiletry items There is some evidence that a very small amount of transmission may occur through the sharing of toothbrushes, razors and other personal toiletry items that could be contaminated with blood. 48 There is no risk of HCV transmission from everyday social contact such as holding hands, hugging or kissing or through sharing toilets, crockery and kitchen utensils. Healthcare workers and others Healthcare workers (and, to a lesser extent, other workers, such as police, prison staff and social workers) may be at risk of hepatitis infection from occupational injuries, for example needle-stick injuries. 49 Estimates of transmission risk following needlestick injury vary, with one large prospective study of 4,403 exposed healthcare workers finding an overall transmission rate of 0.31%, whilst a review of 25 smaller studies reported a combined rate of 1.9% from 2,357 exposures. 50, 51 The relative risk is higher when injuries are deep and from blood-filled needles. Risk arising from superficial or mucocutaneous exposures is likely to be much lower, though difficult to quantify, while transmission from solid needles is extremely unlikely. 51 Transmission occurs only from HCV RNA positive sources.

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